EUCTR2016-001928-54-IT
Active, not recruiting
Phase 1
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer - na
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Enrollment
- 497
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-ECOG performance status 0\-1
- •\- Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
- •\- Ongoing androgen deprivation therapy (ADT) with a Gonadotropin\-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of \=1\.73nmol/L (50ng/dL).
- •For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
- •\- Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 199
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Presence of visceral metastases in the liver
- •\- Active brain metastases or leptomeningeal metastases
- •\- Active, known, or suspected autoimmune disease or infection
- •\- Prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, or anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways.
- •For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
- •\- Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab.
- •\- Have received systemic anti\-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel).
Outcomes
Primary Outcomes
Not specified
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